October 25, 2017 Lisa Stone Principal Regulatory …U.S. Food & Drug Administration 10903 New...
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U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.01.96 Silver Spring, MD 20993 www.fda.gov October 25, 2017 Medtronic, Inc. Lisa Stone Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112 Re: K172626 Trade/Device Name: Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II Product Code: DTZ, DTR, DTN, DTM, JOD Dated: August 31, 2017 Received: September 1, 2017 Dear Lisa Stone: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good
Transcript of October 25, 2017 Lisa Stone Principal Regulatory …U.S. Food & Drug Administration 10903 New...
U.S. Food & Drug Administration 10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 1 . 9 6 Silver Spring, MD 20993 www.fda.gov
October 25, 2017 Medtronic, Inc. Lisa Stone Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112 Re: K172626
Trade/Device Name: Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir
Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II Product Code: DTZ, DTR, DTN, DTM, JOD Dated: August 31, 2017 Received: September 1, 2017
Dear Lisa Stone: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
for
Nicole G. Ibrahim -S
K172626
K172626
K172626
K172626
5 SUMMARY OF SAFETY AND EFFECTIVENESS
Date Prepared: August 31, 2017
Submitter’s Name and Address: Medtronic, Inc.Medtronic Perfusion Systems8200 Coral Sea Street NEMounds View, MN 55112Establishment Registration Number: 2184009
Contact Person: Lisa J. Stone, RACPrincipal Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: (763) 514-9866Email: [email protected]
Alternate Contact: Jake RoellerSenior Regulatory Affairs ManagerMedtronic Perfusion SystemsPhone: (763) 526-0404Email: [email protected]
Proprietary Name: Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Balance™ Biosurface (Model BB811)
Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BB841)
Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface (Model CB811)
Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActiveSurface and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model CB841)
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K172626 page 1 of 6
Common Name: Oxygenator
Classification Name: Cardiopulmonary Bypass Oxygenator
Classification: Classification: Class IIPanel: CardiovascularRegulation: 21 CFR 870.4350Product Code: DTZ
Predicate Device: Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Balance™ Biosurface (Model BB811) – K142784
Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BB841) – K142784 and K132972
Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface (Model CB811) – K142784
Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActiveSurface and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model CB841) –K142784 and K132972
Device Description
Affinity Fusion Oxygenators contain both an integrated arterial filter and integrated heat exchanger. These are microporous, hollow-fiber, gas-exchange devices available with Balance Biosurface or Cortiva BioActive Surface bonded to the blood contacting surfaces.
The Integrated Arterial Filter with Balance Biosurface or Cortiva BioActive Surface is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery.
Additionally, some models are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect
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venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.
Affinity Fusion Oxygenators are designed to be an integral part of the cardiopulmonary heart bypass circuit for use during cardiac surgery. Blood that comes from the patient is delivered through a pump to the oxygenator and other auxiliary devices, and back to the patient.
The oxygenator can be connected to a heater/cooler device, recirculation circuit, cardioplegiacircuit, and the main blood path. These connections are made with tubing connected to barbed or luer ports. The oxygenator is under constant fluid pressure. There is pressure exerted on the blood-side of the device from the blood pump and patient, the water-side of the device due to the flow of the heater-cooler for water, and the gas-side of the device due to the flow of gases through the device. The three compartments (blood-side, water-side and gas-side) must not leak into one another for the oxygenator to function properly.
The water-side of the oxygenator is connected to a heater/cooler device to enable temperature control of the blood. To prevent microbial growth within the heater/cooler, some manufacturers specify the addition of disinfectants to the heater/cooler water. During operation, the water path of the polyethylene terephthalate (PET) heat exchanger is exposed to these disinfectants.
The purpose of this 510(k) Notification is to notify the FDA of a change to allow for the use of hydrogen peroxide (330 ppm) in the water path of the oxygenator. There are no actual changes to the oxygenators.
Indications for Use
There is no change to the intended use of the devices within the scope of the proposed change in this 510(k) Notification. The current Indications for Use statement for each device model are noted below:
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Model BB811)
The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
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The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.
Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BB841)
The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.
The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.
Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva BioActive Surface (CB811)
The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during cardiopulmonary bypass (CPB) surgery.
Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva BioActive Surfaceand Cardiotomy/Venous Reservoir with Balance Biosurface (Model CB841)
The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon
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dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
The Affinity Fusion oxygenator with Integrated arterial filter and Cortiva bioactive surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.
The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.
Comparison to Predicate Devices
When compared to the predicate devices, the Affinity Fusion Oxygenators are substantially equivalent. The oxygenators within scope of this 510(k) Notification have the following similarities:
Same intended use Same operating principle Same fundamental technological characteristics Same design, dimensions and performance Same device materials Same packaging materials and design Same sterilization requirements
Summary of Performance Data
While these devices are subject to special controls, most of the special control requirements are not applicable for this proposed change. During use, the water path of the heat exchanger is the only part of the oxygenator that is exposed to a disinfectant. Because of this, it is not necessary to repeat all recommended testing by the specified special control guidance documents. It is however necessary to conduct testing to verify the chemical disinfectant has no adverse effects on the oxygenator water path. The following testing and analysis was performed:
Heat Exchanger Product Material Compatibility with Hydrogen Peroxide
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Structural Integrity Testing (pressure integrity, burst and port break tests)
Toxicological Risk Assessment for Hydrogen Peroxide
Heat Exchanger Permeability Testing
Conclusion
In conclusion, the information provided within this submission demonstrates the Affinity Fusion Oxygenators with Integrated Filter and Cortiva BioActive Surface or Balance Biosurface, with or without Cardiotomy/Venous Reservoir with Balance Biosurface are substantially equivalent to the marketed predicate devices.
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